HyperplasiaPhase 1/2NCT00086164
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
A Phase 1/2 study testing edifoligide (E2F Decoy) in people with Hyperplasia and Chronic Renal Failure, run by Anesiva, Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hyperplasia, Chronic Renal Failure
- What is being tested?
- edifoligide (E2F Decoy)
- How many people
- Not given
- Where
- 21 sitesUnited States
- Study dates
- May 2004to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)
- Be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index PTFE graft
- Have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins
- Be > 18 and <80 years old
- Have a documented negative serum pregnancy test (for all women of childbearing potential)
- Be using an acceptable method of birth control if of reproductive potential and agree to continue using the birth control for at least 3 months following the graft procedure
- Have agreed to participate voluntarily and have signed and dated an IRB/EC approved, Patient Informed Consent form
Who cannot join
- Have an intended recipient vein >6 mm or <3 mm in diameter
- Have a history of three or more previous PTFE grafts
- Have uncorrected central vein (including the subclavian vein) stenosis
- Have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or Doppler ultrasound)
- Anticipate receipt of a renal transplant within 6 months of enrollment into this study
- Have anticipated use of the index PTFE graft <14 days after enrollment (this does not apply to Vectragraft®)
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- Have a known allergy to iodinated contrast
- Have a known hypercoagulable state (e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating lupus anticoagulant; current, active, heparin-induced thrombocytopenia; Protein C or S deficiency; or a history of recurrent deep venous thrombosis not related to AV access)
- Have been in another investigational (i.e., nonapproved) drug or device study within the previous 30 days or prior participation in another clinical study with E2F Decoy
- Have been previously enrolled in this study for an earlier access graft
- Have any comorbid, nonrenal condition that makes 6-month survival questionable (e.g., end-stage cancer, advanced heart failure)
- Have a known or suspected history of drug or alcohol abuse within the previous 6 months
- Have a known allergy to any component of the investigational product (drug or device), including latex
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University, Renal Division
Atlanta, Georgia, 30322
Vascular Surgery Associates
Baton Rouge, Louisiana, 70808
Nephrology Clinical Research Center
Charlottesville, Virginia, 22908
University Transplant
Chicago, Illinois, 60612
Stoney Island Dialysis
Chicago, Illinois, 60617
Henry Ford Hospital
Detroit, Michigan, 48202
Surgical Education
Greenville, South Carolina, 29605
Outcomes Research International, Inc.
Hudson, Florida, 34667
Methodist Hospital, Tower Surgical
Indianapolis, Indiana, 46202
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
National Institute of Clinical Research, American Medical Tower
Los Angeles, California, 90017
University of Miami, School of Medicine
Miami, Florida, 33136
Tulane Center for Abdominal Transplant
New Orleans, Louisiana, 70112
NYU Medical Center
New York, New York, 10016
St. Luke's Hospital, Department of Surgery
New York, New York, 10025
University of Rochester, The Center for Vascular Disease
Rochester, New York, 14642
University of Utah School of Medicine, Dept of Surgery
Salt Lake City, Utah, 84132
St. Louis University, Division of Nephrology
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33600
LifeLink Transplant Institute
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft With Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients With Chronic Renal Failure Requiring Hemodialysis
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.
- Conditions
- Hyperplasia, Chronic Renal Failure
- Being tested
- edifoligide (E2F Decoy)
- Keywords
- edifoligide, E2F Decoy, Chronic Renal failure, hemodialysis, AV Graft, neointimal hyperplasia
- Medical subject headings
- Hyperplasia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edifoligide (E2F Decoy)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2004 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086164
- Sponsor's protocol ID
- CGT003-05
- Status last verified
- Jul 2005
- First submitted
- 25 Jun 2004
- Last updated
- 19 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft With Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients With Chronic Renal Failure Requiring Hemodialysis
- ClinicalTrials.gov ID
- NCT00086164
- Acronym / sponsor ID
- CGT003-05
- Conditions
- Hyperplasia, Chronic Renal Failure
- Keywords
- edifoligide, E2F Decoy, Chronic Renal failure, hemodialysis, AV Graft, neointimal hyperplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 29 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)
- Be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index PTFE graft
- Have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins
- Be > 18 and <80 years old
- Have a documented negative serum pregnancy test (for all women of childbearing potential)
Key exclusion criteria (13 listed)
- Have an intended recipient vein >6 mm or <3 mm in diameter
- Have a history of three or more previous PTFE grafts
- Have uncorrected central vein (including the subclavian vein) stenosis
- Have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or Doppler ultrasound)
- Anticipate receipt of a renal transplant within 6 months of enrollment into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edifoligide (E2F Decoy) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing edifoligide (E2F Decoy) in people with Hyperplasia and Chronic Renal Failure, run by Anesiva, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2005.